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Patients provided written consent for participation in the study prior to cardiac catheterization. Diagnostic coronary angiography was performed utilizing standard techniques. Patients in whom the operator believed needed physiologic coronary assessment with Fractional Flow Reserve (FFR) were then eligible for participation in the study.

Pre-assignment Details

Arm/Group Title

Adenosine Then Regadenoson

Arm/Group Description

Adenosine infusion will be compared...

Arm/Group Description

Adenosine infusion will be compared to Regadenoson for efficacy and safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias. All patients to receive Adenosine infusion followed by Regadenoson IV bolus upon return of coronary flow velocity to 15% of pre-dose value.

Each patient underwent standard intravenous adenosine infusion (140mcg/kg/min) with invasive pressure recordings for 2 min, or until maximal hyperemia occurred. Five minutes after return to baseline hemodynamics, a single intravenous bolus of 0.4 mg regadenoson was administered, and pressures were recorded for 5 min. FFR values were compared by linear regression and Bland-Altman analysis.

Overall Number of Baseline Participants

46

Baseline Analysis Population Description

...

Baseline Analysis Population Description

Patients with intermediate to severe, single vessel or multi-vessel, angiographic coronary artery disease(visual 40%-70% angiographic stenosis) whose lesion assessment with FFR is planned, were eligible for enrollment. A total of up to 50 subjects(25 at University of Florida Health Science Center and 25 at St. Louis University) will be enrolled.

FFR (as calculated by the ratio of lowest Pd/Pa at maximal hyperemia) ...

Description

FFR (as calculated by the ratio of lowest Pd/Pa at maximal hyperemia) was compared between hyperemia achieved with adenosine and with regadenoson

Time Frame

At maximal, steady-state hyperemia

Outcome Measure Data Outcome Measure Data

Analysis Population Description

Analysis Population Description

Per protocol

Arm/Group Title

Adenosine

Regadenoson

Arm/Group Description:

Adenosine infusion will be compared...

Once the mean coronary flow velocit...

Arm/Group Description:

Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias.

Once the mean coronary flow velocity returns to within 15% pre-dose value following IV infusion of Adenosine, Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml over 10 seconds followed by a 5 cc IV saline flush.

Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias.

Once the mean coronary flow velocity returns to within 15% pre-dose value following IV infusion of Adenosine, Regadenoson IV injection will be given at 0.4 mg 5/ml- 0.08mg/ml over 10 seconds followed by a 5 cc IV saline flush.

Adenosine infusion will be compared to Regadenoson for safety/side effects. Arterial blood pressure, coronary pressure, heart rate, oxygen saturation and coronary flow, FFR, and coronary flow velocity will be assessed. Safety will be assessed by monitoring for any side effects such as chest pain, headache, flushing, nausea, or arrhythmias.